Recruiting
Phase 3

Exparel vs. Bupivacaine

Sponsor:

Abington Memorial Hospital

Code:

NCT03304444

Conditions

Gynecologic Cancer

Post Operative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Bupivacaine

liposomal bupivacaine

Study Details

Brief summary:

This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.

Conditions

Gynecologic Cancer

Post Operative Pain

Study ID

NCT03304444

Start date

Aug, 2016

Status verified date

Oct, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • all patients undergoing planned exploratory laparotomy
  • TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
  • Consent for TAP block signed by patients preoperatively by anesthesiology

Exclusion Criteria:

  • All pregnant patients
  • All patients under 18 years of age
  • minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
  • medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Bupivacaine HCl in TAP block

When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials).

When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.

experimental: Liposomal Bupivicaine in TAP block

When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.

Interventions

Bupivacaine

bupivacaine hydrochloride used in TAP block

liposomal bupivacaine

liposomal bupivacaine used in TAP block

Primary outcome measure

  • Length of stay post operatively in hospital [ Time Frame: through study completion, expected to be approximately 1 year in total ]

Central Contacts and Locations

Central contacts

Heidi Ching, MD

215-481-4231heidi.ching@jefferson.edu

Mark Shahin, MD

215-885-0220mark.shahin@jefferson.edu

Locations

Abington Hospital Jefferson Health

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Mark Shahin, MD

215-885-0220mark.shahin@jefferson.edu

Heidi Ching, MD

215-481-4211heidi.ching@jefferson.edu

More Information

Sponsor

Abington Memorial Hospital

Last update posted

Oct 9, 2017

Last verified

Oct, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abington Memorial Hospital on 2017-10-09.